Overview
SUMMARY
The compliance specialist is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control, training and batch record review.
The compliance specialist will support cGMP and site quality compliance goals within manufacturing department. He/She will also manage continuous improvements and efficiency projects
Duties And Responsabilities
- Ensure that the systems are ready for inspection at all time
- Raise, investigate, assess and close Deviation within timelines
- Define and plan CAPA to avoid recurrence and allow process improvement.
- Define and plan effectiveness check
- Manage Change Controls Process as compliance resolution or for continuous improvement.
- Define and maintain KPI for manufacturing support group regarding quality and operational performance
- Act as SME during Heath Authorities inspection by presenting Risk Aassessment, Deviations, Investigations, CCP and CAPAs
- Develop and maintains business KPI’s and proposes/supports continuous improvements
- Author, review and approve SOP/WI or any manufacturing supporting document
- Act as a mentor to DSP manufacturing team members and lead by example to ensure integration of good manufacturing practices
- Coach and train Manufacturing Staff to GMP guidelines and sub-departement specific SOP
- Provide Training Polyvalence Overview within sub-department
- Proactively propose problem resolution to process and DSP equipment
- Review and support the review of executed batch report (exception review)
- Implement quality compliance initiatives in the department in collaboration with QA
- Coach and support other team members for quality compliance matters (such as deviation and changes management)
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines
- Delegate to: DSP Manager / Process Support Manager
Requirements
- BSc, Master or Engineering Degree in Pharma/Biotech engineering
- Relevant experience in biotech industry related to cGMP drug manufacturing and quality.
- Direct experience in FMEA, root cause analysis, and associated quality assessment tools
- Typically minimum 3-5 years of experienceAbility to work in a fast paced – high regulated environment
- French and English (Fluent)
- Team work oriented mindset
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Specialist Compliance DSP Arbeitgeber: Incyte
Incyte bietet eine herausragende Arbeitsumgebung, die von einer Kultur der Zusammenarbeit, Innovation und kontinuierlichen Entwicklung geprägt ist. Als Senior Business Unit Director im Bereich Hämatologie/Onkologie in Deutschland haben Sie die Möglichkeit, nicht nur die strategische Ausrichtung eines wachsenden Geschäfts zu gestalten, sondern auch aktiv zur Verbesserung der Patientenversorgung beizutragen. Mit einem starken Fokus auf Mitarbeiterentwicklung und einem dynamischen Arbeitsumfeld, das kreative Lösungen fördert, ist Incyte der ideale Arbeitgeber für Führungspersönlichkeiten, die einen bedeutenden Einfluss ausüben möchten.
